The FDA has granted 510(k) market clearance for the FluChip-8G Influenza A+B Assay, according to manufacturer InDevR Inc.
FluChip-8G is the first cleared influenza diagnostic capable of positively characterizing a wide variety of viruses as “non-seasonal” and characterizing seasonal viruses in a single multiplexed assay with same-day results.
The in vitro diagnostic assay was developed for the qualitative detection and differentiation of seasonal and non-seasonal influenza A viruses as well as the genetic lineage of influenza B viruses.
Importantly, the assay is capable of detecting a wide variety of non-seasonal influenza A viruses and positively identifying them as “non-seasonal,” including subtypes with recognized pandemic potential such as H7N9 and H5N1.
The open platform molecular diagnostic system consists of a low-density microarray and reagent kit, microarray imaging system, and custom software. The assay is based on multiplexed RT-PCR amplification of whole influenza gene segments in combination with detection on a microarray and subsequent AI-based pattern-recognition for automated interpretation.
“This successful clearance follows several years of assay development with the goal of improving the nation’s preparedness to respond to an influenza pandemic,” said Dr Erica Dawson, InDevR’s Chief Technology Officer. “We hope that placement of this FluChip-8G technology in the field will bring us another step closer to ensuring timely detection of emerging influenza threats.”